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Trial registered on ANZCTR


Registration number
ACTRN12623000899640p
Ethics application status
Submitted, not yet approved
Date submitted
11/07/2023
Date registered
22/08/2023
Date last updated
22/08/2023
Date data sharing statement initially provided
22/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of outcomes of fixated fully covered duodenal metal stents versus uncovered duodenal metal stents for patients with malignant gastric outlet obstruction – a pilot randomized trial
Scientific title
Comparison of stent patency with fixated fully covered duodenal metal stents versus uncovered duodenal metal stents for patients with malignant gastric outlet obstruction – a pilot randomized trial
Secondary ID [1] 310096 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Outlet Obstruction 330660 0
Condition category
Condition code
Cancer 327473 327473 0 0
Pancreatic
Cancer 327474 327474 0 0
Stomach
Oral and Gastrointestinal 327475 327475 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised, in 1:1 ratio, to receive either:
i) “Covered” stent (C-SEMS), the comparator group; or
ii) “Uncovered” stent (U-SEMS), the intervention group.
for treatment of malignant gastric outlet obstruction.

Stent insertion will occur via endoscopic procedure by an endoscopist. Mode of sedation will be as per anaesthetic team. A therapeutic endoscope (3.7mm working channel) approaches the gastric or duodenal stenosis site. A guidewire and catheter was then passed through the stenosis and distally, with endoscopic and fluoroscopic guidance. Using a balloon, the stenosis length is approximated. With consideration for shortening of the stent after extension a SEMS of appropriate length is chosen (6/9/12mm). The SEMS is then placed under endoscopic and fluoroscopic guidance.
A Stenting procedure is expected to take approximately 1 hour.
Patients will be followed up at 1-month, 3-month, and 6-month timepoints, via on-site visits with investigators, and consulting patient medical and surgical records.
Intervention code [1] 326496 0
Treatment: Other
Comparator / control treatment
The comparator group are the patients allocated the "Covered" stent (C-SEMS). Though both "Uncovered" (U-SEMS) and C-SEMS are considered standard treatments for for this illness, and multiple studies have assessed U-SEMS vs C-SEMS, more research is needed to effectively compare diagnostic outcomes between the two.

If the participant is assigned to the Covered stent group, then there will be an additional technique used to ‘anchor’ the stent in place by using stiches, via a suturing device that is placed at the tip of the endoscope. This will take an extra 5-10 minutes to allow for 'anchoring' of the C-SEMS via OverStitch Suturing system.
Control group
Active

Outcomes
Primary outcome [1] 335342 0
Stent Patency Rate, defined as the percentage of patients with patent stents (not requiring re-intervention). Participants who are asymptomatic after the stenting procedure will not require scanning, but those who exhibit symptoms after the stenting procedure will undergo CT scan for assessment.
Timepoint [1] 335342 0
This will be assessed in individual patients at follow up visits conducted at 3- and 6-months post placement. The stent patency rate will be evaluated at conclusion of the study
Secondary outcome [1] 424009 0
Stent patency duration, defined as the time of stent dysfunction from time of stent placement. Participants who are asymptomatic after the stenting procedure will not require scanning, but those who exhibit symptoms after the stenting procedure will undergo CT scan for assessment.
Timepoint [1] 424009 0
This will be observed at follow up visits conducted at 1 month, 3 months, and 6 months post stent insertion.
Secondary outcome [2] 424010 0
Technical success of stent insertion, defined as successful placement of stent confirmed via endoscopy. This will be collected via consulting patient medical and surgical records.
Timepoint [2] 424010 0
Assessed immediately following stent insertion on the procedure day and 3 days post stent insertion.
Secondary outcome [3] 424011 0
Clinical Success, defined by the Gastric Outlet Obstruction Scoring System (or GOOSS).
GOOSS 4 point scale:
0 = no oral intake
1 = liquids only
2 = soft solids only
3 = low residue or full diet
Improvement will be defined of at least 1-point GOOSS.
Timepoint [3] 424011 0
Improvement of at least 1-point GOOSS within 3 days of stent insertion.
Secondary outcome [4] 424012 0
Quality of life, assessed by EORTC QLQ-C30.
Defined as scores from 1-4 with lower score representing better response.
Timepoint [4] 424012 0
EORTC QLQ-C30 will be assessed at procedure visit (prior to procedure), and each follow up visit at 1 month, 3 months, and 6 months.
Secondary outcome [5] 424013 0
Quality of life, assessed by EORTC STO-22.
Defined as scores from 1-4 with lower score representing better response. Specific to gastric cancer.
Timepoint [5] 424013 0
EORTC STO-22 will be assessed at procedure visit (prior to procedure), and each follow up visit at 1 month, 3 months, and 6 months
Secondary outcome [6] 424031 0
Stent dysfunction rate, defined as restenosis due to tumour ingrowth/migration/fracture within 6 months. Participants who are asymptomatic after the stenting procedure will not require scanning, but those who exhibit symptoms after the stenting procedure will undergo CT scan for assessment.
Timepoint [6] 424031 0
This will be observed for at follow up visits conducted at 1 month, 3 months, and 6 months post stent insertion, or when patient is presented with stent dysfunction during this 6-month post-stent insertion period.
Secondary outcome [7] 424032 0
Mortality, defined as death by any cause.
Timepoint [7] 424032 0
Assessed from day of stent insertion, and followed up until 6 months post stent insertion

Eligibility
Key inclusion criteria
Patients required to have stents inserted for treatment of malignant gastric outlet obstruction (mGOO, defined as patients with malignant Gastric Outlet Obstruction Scoring System (GOOSS) of <2).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior metallic stent placement
Prior gastric surgery
Pregnancy
Eastern Cooperative Oncology Group (ECOG) score >3
Severe comorbidities precluding endoscopic procedure
Life expectancy of less than 1 month
Unable to provide informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The recruited patients will be randomized, in a 1:1 ratio, to either C-SEMS or U-SEMS group. The assigned approach of stent insertion will be obtained after central randomisation via computer generation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2023
Actual
Date of last participant enrolment
Anticipated
1/09/2024
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 25114 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 40781 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 314259 0
Hospital
Name [1] 314259 0
Royal Adelaide Hospital
Country [1] 314259 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Port Road, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 316198 0
None
Name [1] 316198 0
Address [1] 316198 0
Country [1] 316198 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313378 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 313378 0
CALHN Research Office RAH Clinical Trial Centre Level 3, Royal Adelaide Hospital Port Road ADELAIDE SA 5000
Ethics committee country [1] 313378 0
Australia
Date submitted for ethics approval [1] 313378 0
12/07/2023
Approval date [1] 313378 0
Ethics approval number [1] 313378 0

Summary
Brief summary
This study aims to compare the efficacy of two types of Self-Expandable Metallic Stents (SEMS) in the treatment of gastric malignancies.

Who is it for?
The study is looking for participants that are required to have stents inserted for treatment of malignant gastric outlet obstruction (or “GOO”).

Purpose of the study
Self-Expandable Metallic Stent (or SEMS) are placed to open a stricture or tightening within the small bowel that is causing your symptoms, as food cannot pass through from the stomach into the small bowel. Uncovered stents (U-SEMS) are often placed to open this but there is the risk of tumour growing into the stent. When the stent is covered (C-SEMS), the tumour cannot grow into the stent. However, there is the risk of the stent moving (migrating).
Though there have been multiple studies assessing the difference between C-SEMS and U-SEMS, and there are both advantages and disadvantages to using either, newer comparison studies are needed, as the introduction of recent technological developments have allowed for better SEMS fixation it is not clear which type of technique is preferred.

Study Details
We aim to compare the differences of two types of Self-Expandable Metallic Stents (SEMS) for GOO relief:
• “Covered” SEMS (C-SEMS), and
• “Uncovered” SEMS (U-SEMS).
These two types will be assessed in terms of stent patency, technical success, clinical success, and safety. These will be assessed at the day of the procedure, and three follow-up visits.
We are particularly interested in comparing the stent patency rate between groups; the percentage of participants with stents that do not require re-intervention at 3- and 6-months post placement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127938 0
Prof Nam Nguyen
Address 127938 0
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Port Road, Adelaide, South Australia, 5000
Country 127938 0
Australia
Phone 127938 0
+61 8 7074 2124
Fax 127938 0
+61 8 7074 6192
Email 127938 0
quocnam.nguyen@sa.gov.au
Contact person for public queries
Name 127939 0
Mr Joshua Zobel
Address 127939 0
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Port Road, Adelaide, South Australia, 5000
Country 127939 0
Australia
Phone 127939 0
+61 8 7074 2188
Fax 127939 0
+61 8 7074 6192
Email 127939 0
joshua.zobel@sa.gov.au
Contact person for scientific queries
Name 127940 0
Mr Joshua Zobel
Address 127940 0
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Port Road, Adelaide, South Australia, 5000
Country 127940 0
Australia
Phone 127940 0
+61 8 7074 2188
Fax 127940 0
+61 8 7074 6192
Email 127940 0
joshua.zobel@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval will not include making IPD available. Individual information will be de-identified and will not be disclosed to the public.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.